TheranosticTrials.org

Clinical Trial · NCT06565247

Evaluation of PSMA-PET and mpMRI in High-risk Prostate Cancer - Using Histopathologic Validation

Overview

In this trial the connection between image properties (mpMRI and PSMA-PET) and tissue properties (molecular and histopathology) will be investigated in order to improve diagnostics and image-based treatment guidance of prostate cancer.

Sponsor

Region Västerbotten

Phase

Phase 3

Contacts

Camilla Thellenberg Karlsson, MD, PhD (CONTACT)

camilla.thellenberg@umu.se

+46907850000

Camilla Thellenberg Karlsson, MD, PhD (PRINCIPAL_INVESTIGATOR)

Tufve Nyholm, PhD (CONTACT)

tufve.nyholm@umu.se

+46907850000

ClinicalTrials.gov

NCT06565247

Drug / Compound

PSMA

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules

Eligibility

Inclusion

  • ≥4 weeks since last biopsy of the prostate
  • \>18 years
  • Given a written consent to participate in the trial
  • PSMA-PET/CT conducted as part of the clinical management for the existing prostate cancer.
  • One or more of the following criteria
  • PSA 20-49 ng/ml
  • Histologically confirmed prostate cancer planned to be treated with radical prostatectomy
  • cT3, or high suspicion of extra prostatic growth on mpMRI
  • Gleason score ≥8

Exclusion

  • Patients treated with neoadjuvant/concomitant anti-testosterone treatment (surgical or medical castration or anti-androgens)
  • Non-MR-safe implants or another contraindication to MRI or PET
  • Metastatic disease in skeleton, parenchymal organs, or lymph nodes outside the pelvis.
  • TUR-P within 6 months
  • WHO PS \>1
  • Patients with previous diagnosis of other malignant disease. Exceptions could be made for basal cell carcinoma of the skin or progression free survival at least 10 years after any previous tumour.
  • Tinnitus or severe hearing loss
  • Unfit for MRI or PET/MRI examination for any other reason, e.g., back pain
  • Claustrophobia
  • Creatinine clearance \< 30ml/min (acc. to http://www.fass.se/LIF/produktfakta-/kreatinin.jsp)